WaveSense Jazz Blood Glucose Monitoring System

K241304 · Agamatrix · NBW · Jun 6, 2024 · Clinical Chemistry

Device Facts

• Record ID: K241304
• Device Name: WaveSense Jazz Blood Glucose Monitoring System
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 6, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

WaveSense Jazz Blood Glucose Monitoring System; in vitro diagnostic device for quantitative glucose measurement in capillary whole blood. System comprises meter, test strips, and control solution. User applies blood sample to test strip; meter performs electrochemical analysis to determine glucose concentration. Modifications include addition of target range indicator colors to meter housing; software update to display glucose measurement status (below, within, or above user-set target range); LCD display layout adjustment; updated disinfection instructions. Used by patients at home for self-monitoring of diabetes. Output displayed on LCD; informs patient of glucose level relative to target range to assist in diabetes management. Device validated for 5-year single-patient use with Super Sani-Cloth Germicidal Disposable Wipes.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by verification and validation activities, including robustness testing, firmware functional testing, and usability engineering evaluations.

Technological Characteristics

Electrochemical glucose monitoring system. Modifications: added target range indicator colors to housing, updated LCD display, software-based target range notification. Validated for 5-year use with Super Sani-Cloth Germicidal Disposable Wipes (EPA Reg. No. 9480-4).

Indications for Use

Indicated for persons with diabetes for quantitative measurement of glucose in fresh capillary whole blood from finger stick, palm, or forearm. For home (OTC) use as an aid to monitor diabetes control. Not for use with neonates.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• WaveSense Jazz Blood Glucose Monitoring System (K072413)

Submission Summary (Full Text)

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June 6, 2024

AgaMatrix Dave Valcourt Regulatory Affairs Manager 7C Raymond Ave Salem, New Hampshire 03079

Re: K241304

Trade/Device Name: WaveSense Jazz Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 9, 2024 Received: May 9, 2024

Dear Dave Valcourt:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

Submission Number (if known)

K241304 Device Name

WaveSense Jazz Blood Glucose Monitoring System

#### Indications for Use (Describe)

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

Prepared on: 2024-06-04

### Contact Details

## 21 CFR 807.92(a)(1)

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

| Applicant Name | AgaMatrix |
|-----------------------------|---------------------------------------------|
| Applicant Address | 7C Raymond Ave Salem NH 03079 United States |
| Applicant Contact Telephone | 603-328-6079 |
| Applicant Contact | Dave Valcourt |
| Applicant Contact Email | [e-mail] |

21 CFR 807.92(a)(2)

| Device Trade Name | WaveSense Jazz Blood Glucose Monitoring System |
|---------------------|------------------------------------------------|
| Common Name | Blood Glucose Monitoring System |
| Classification Name | System, Test, Blood Glucose, Over the Counter |
| Regulation Number | 862.1345 |
| Product Code(s) | NBW |

21 CFR 807.92(a)(3)

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K072413 | WaveSense Jazz Blood Glucose Monitoring System | NBW |

21 CFR 807.92(a)(4)
The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for *in vitro* diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

21 CFR 807.92(a)(5)
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (*in vitro* diagnostic use). It is indicated for use at

blood from the fingerstick, palm and/orforearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

## Indications for Use Comparison

The indications for use of the candidate device are the indications for use of the predicate device with the following changes: the candidate device is not indicated for prescription use and is not indicated for clinical use.

## Technological Comparison

The candidate WaveSense Jazz BGMS has the same fundamental scientific technology as the predicate WaveSense Jazz BGMS. The differences between the candidate WaveSense Jazz BGMS and the predicate are the introduction of new colors on the top housing and the introduction of a new data management feature.

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Activities to verify and validate the modification and robustness testing, firmware functional testing and usability engineering evaluations.

Based on the verification and validation results, the candidate WaveSense Jazz Blood Glucose Monitoring System is substantially equivalent to the predicate WaveSense Jazz Blood Glucose Monitoring System (K072413).